SY4-1 - The Requirement of Fih Study Sites and New Role of Japan for Early Clinical Development: The Pharmaceutical Companies' View

Abstract

ABSTRACT Recently one of the major trends of anti-cancer development has shifted to molecularly targeted drugs due to remarkable progress of cancer biology and cancer science. Translational research, including biomarker investigations and preclinical pharmacology studies, has been proactively introduced before first in human (FIH) studies in order to raise the success rate of total clinical development from FIH to registration. Regrettably the success rate of registration has not been improved, even though the total research costs before FIH studies have increased. Reductions in clinical development costs were taken as the first step to resolve this issue; Cost reduction such as selecting study sites in Asian countries except for Japan. Asian study sites, like Korea, have improved their quality and skill in conducting clinical studies and are now almost qualified enough for FIH or POC studies. Japanese study sites have made great efforts to improve the quality and capacity. Now again many pharmaceutical companies are starting to pay attentions to Japanese study sites as a leader of early development in Asian region. This means the industry is now moving forward to the second step. Most of companies are engaging in external collaborations for translational researches and early clinical development in order to increase the success rate of early clinical development and to speed up the total development. In other words, study sites, which can proactively collaborate with the industry for translational research and conduct investigator initiated trials, will be chosen as an FIH study site or a POC study site. Here, I will make a presentation about how Japan sites can be chosen as an FIH study site or a POC study site as well as a new role for Japanese study sites for early clinical development.